Label: EZETIMIBE tablet

  • NDC Code(s): 70771-1109-0, 70771-1109-1, 70771-1109-2, 70771-1109-3, view more
    70771-1109-4, 70771-1109-5, 70771-1109-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2022

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    NDC 70771-1109-3 in bottle of 30 tablets

    Ezetimibe Tablets , 10 mg

    Rx only

    30 tablets

    Ezetimibe Tablets, 10 mg
  • INGREDIENTS AND APPEARANCE
    EZETIMIBE 
    ezetimibe tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24) EZETIMIBE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size9mm
    FlavorImprint Code 773
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1109-330 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    2NDC:70771-1109-990 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    3NDC:70771-1109-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    4NDC:70771-1109-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    5NDC:70771-1109-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    6NDC:70771-1109-410 in 1 CARTON08/09/2017
    6NDC:70771-1109-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20433108/09/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1109) , MANUFACTURE(70771-1109)
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